Effects of Drospirenone Versus Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women

  • STATUS
    Recruiting
  • End date
    Mar 22, 2027
  • participants needed
    1710
  • sponsor
    Insud Pharma
Updated on 4 October 2022
bone mineral density
menstrual period
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the impact of LF111 (drospirenone) on bone mineral density at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods.

Description

This is a Phase IV, prospective, multicenter, open-label, controlled, non-randomized trial in female subjects between 14 to 45 years of age who are postmenarcheal for at least two years and premenopausal. Subjects who choose to take the trial medication (LF111) will be compared to subjects who choose to use non-hormonal contraceptive methods, enrolled in a 1:1 ratio. Subjects will also be separated into two cohorts, cohort 1 as adolescents aged 14-17, and cohort 2 as adults aged 18-45.

At Visit 1 (screening), informed consent/assent will be obtained, and the screening procedures will be performed. At Visit 2 (allocation to treatment), after confirming the subject's eligibility, subjects who choose to use LF111 for pregnancy prevention will be provided LF111. The subjects will attend additional on-site visits 6 months and 12 months after Visit 2 (end of investigational phase) or within one week after premature trial discontinuation for routine safety assessments.

The primary objective of this study is to evaluate the impact of LF111 on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods. Secondary objectives include further evaluating the impact of LF111 on BMD and bone turnover after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods and assessing the general safety and tolerability of LF111 in comparison to non-hormonal contraceptive methods. Exploratory objectives include evaluating the impact of LF111 on body fat and lean mass after 12 months (13 medication cycles) of investigation.

Details
Condition Change in Bone Mineral Density, Bone Loss
Treatment LF111 (drospirenone)
Clinical Study IdentifierNCT05303636
SponsorInsud Pharma
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female subjects with regular menstrual cycles (postmenarcheal for at least two years and premenopausal) aged 14 to 45 years
Female subjects aged between 14 to 17 years (inclusive) will only be included provided
that
Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed
Systolic blood pressure < 130 mmHg, diastolic blood pressure < 80 mmHg at Visit 1, in
sitting position after 5 minutes of rest
Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant)
Be able and willing to provide written informed consent, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures
Willing to use trial contraception for thirteen 28-day cycles (LF111 arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively

Exclusion Criteria

Contraindications to the use of LF111 (such as active arterial or venous thromboembolic disorders, liver tumors benign or malignant, hepatic impairment, renal impairment, adrenal insufficiency, presence or history of cervical cancer or progestin-sensitive cancers, known or suspected sex-steroid sensitive malignancies, undiagnosed abnormal uterine bleeding, undiagnosed vaginal bleeding, hypersensitivity to active substance or excipient) or adverse effects due to previous contraceptive use (for the LF111 arm only)
BMD Z-score below -1.5
Low trauma fracture(s) defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face, and skull
Medical conditions associated with low bone mass
Metabolic bone disease such as osteogenesis imperfecta, Paget's disease of the bone, osteomalacia/rickets
Collagen vascular diseases such as Marfan syndrome and Ehlers-Danlos syndrome
Chronic kidney disease stage 3 with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Bedside Schwartz equation for adolescents and the Modification of Diet in Renal Disease (MDRD) method for adult subjects
Gastrointestinal (malabsorptive) disease including inflammatory bowel disease, gastric bypass surgery and current post-gastrectomy syndrome
Liver disease
Abnormal bone mineral metabolism (hypocalcemia/hypercalcemia, hypophosphatemia/hyperphosphatemia, hypomagnesemia)
In adolescents only: Short stature defined as height-for-age percentile less than the
fifth percentile
Use of oral, transdermal, vaginal, or intrauterine hormonal contraceptives in the previous month (within the previous 3 months in case of containing estrogen) or use of injectable or implantable hormonal contraceptives in the previous 6 months
Laboratory values at Screening which are considered clinically significant and which in the opinion of the investigator would be detrimental for participation in the study
Ongoing pregnancy or wish for pregnancy
Currently lactating or stopped lactating within the past year
Eating disorders (e.g., anorexia nervosa, bulimia)
Celiac disease
Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease)
Rheumatoid arthritis
Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium
Treatment with medications that are known to decrease bone mass
Glucocorticoids (oral, intravenous, chronic inhaled, chronic extensive topical) within the previous 3 months. Note: Subjects taking chronic oral/intravenous glucocorticoids (prednisone ≥ 2.5 mg daily for ≥ 3 months, or the equivalent) will have a washout period of 12 months
Depo-medroxyprogesterone acetate within the previous 24 months (if duration of use was less than 2 years). Note: Subjects using depo-medroxyprogesterone acetate for a duration of use greater than 2 years will be excluded
Aromatase inhibitors and/or raloxifene within the previous 24 months
Anticonvulsants (phenytoin, phenobarbital, carbamazepine and valproate), anti-retroviral protease inhibitors, cyclosporine, heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitor (PPI) use, selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months
Conditions that preclude BMD measurement i.e. lumbar spine/bilateral hip surgery with
hardware in place, abdominal clips, umbilical ring (not willing to remove) or
weight that exceeds the DXA machine limitation
Any condition that, in the opinion of the investigator, may jeopardize the trial conduct according to the protocol
Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
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